Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT06781632
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers based on the results of medical evaluation, including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring, performed by the investigator.
* Between 18 and 45 years, male and female
* Provide a signed and dated written informed consent
* A negative pregnancy test at the screening visit for female volunteers with childbearing potential
* Negative alcohol breath test.
* Negative urine drug screening for addictive substances (amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opioids).
* Capable of completing all tests and evaluations related to the study.
* In the investigator's opinion, the volunteer must have the potential to comply with the study requirements.
Exclusion Criteria:
* Volunteers with hypersensitivity to local anesthesia/regional anesthesia.
* Volunteers with a known hypersensitivity to amide-based local anesthetics.
* Volunteers with chronic pain.
* Volunteers with neuromuscular diseases or peripheral neuropathy.
* Volunteers with bleeding disorders/coagulopathies.
* Volunteers with a history of motor or sensory loss in the lower extremities.
* Volunteers with a history of arrhythmia or seizures.
* Volunteers with renal or hepatic insufficiency.
* Volunteers diagnosed with diabetes.
* Volunteers with hereditary neuropathy.
* Volunteers with a body mass index (BMI) \> 35 kg/m².
* Pregnant, breastfeeding, or women with a positive pregnancy test.
* Volunteers with skin infections or wounds at the injection site.
* Volunteers with clinically significant abnormalities in the ECG, such as rhythm, conduction, or morphology issues, or any abnormalities on a 12-lead ECG that could interfere with the interpretation of QTc interval changes (including normal ST-T wave morphology or left ventricular hypertrophy), as determined by the investigator or medical monitor, or those on chronic use of antiarrhythmic medications.
* Volunteers with clinically significant abnormalities in vital signs during screening, which may include:
1. systolic blood pressure \< 90 or \> 140 mmHg,
2. diastolic blood pressure \< 50 or \> 95 mmHg,
3. heart rate \< 45 or \> 100 beats/min, measured three times at 5-minute intervals in a seated position.
* Volunteers with any condition (medical, psychological, social, etc.) that may impair their ability to comply with the study, as assessed by the investigator.
* Volunteers currently participating in another clinical study.
* Volunteers with a positive urine drug screening and/or alcohol test.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06781632
Study Brief:
Protocol Section:
NCT06781632